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Na 116240

by MAKO Surgical Corp.

Ref 116240Model 08858251002253SH

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None ongoing

16 closed

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08858251002253SH Basic UDI-DI 00848486002985UDI-DIDate5 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00848486002985 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

16 recalls · FDA

    • Terminated Z-1735-2022 FDA Class II initiated 8 Aug 2022

    Certain units have the potential to exhibit infant failures whereby units either arrive non-functional, have the potential to become non-functional, or flash an error light while in use.

  • 2 recalls, same reason

    • Terminated Z-2924-2018 FDA Class II initiated 24 Jul 2018
    • Terminated Z-2925-2018 FDA Class II initiated 24 Jul 2018

    Specific lots of the Vizadisc Knee Procedure Tracking Kit and Vizadisc Hip Procedure Tracking Kit have the potential to be damaged on the Vizadisc reflective material causing an inability to be detected by the camera.

  • 2 recalls, same reason

    • Terminated Z-3130-2017 FDA Class II initiated 7 Aug 2017
    • Terminated Z-3131-2017 FDA Class II initiated 7 Aug 2017

    Software discrepancy of not showing all the EE constants, when the screen is filled.

    • Terminated Z-2741-2017 FDA Class II initiated 7 Jun 2017

    An intermittent electrical problem that could lead to a loss of system power due to a loose screw connection.

    • Terminated Z-1411-2017 FDA Class II initiated 22 Dec 2016

    Five (5) AFMEA Risk Control Measures are missing from the MAKO RIO THA Application User Guides

    • Terminated Z-1193-2017 FDA Class II initiated 29 Sep 2016

    Failure of the Offset Cup Reamer Handle not engaging its mating components.

    • Terminated Z-1583-2016 FDA Class II initiated 23 Feb 2016

    Potential disassociation of the orientation pin.

    • Terminated Z-1588-2016 FDA Class II initiated 25 Nov 2015

    Stryker Orthpaedics became aware that there is the potential for the 210540 MAKOplasty Hip Array Kit Laminate 150230 to list two part numbers for the RIO Base Array, which is item #5 on the product table.

    • Terminated Z-0224-2016 FDA Class II initiated 16 Jul 2015

    The locking pin on the RIO Base Array is damaged during assembly onto the RIO Base Array Connector.

    • Terminated Z-1128-2015 FDA Class II initiated 22 Jan 2015

    When using the MAKOplasty partial knee Arthroplasty application, the burr continues spinning outside of the stereotactic boundary and after the control switches (foot pedal and trigger) cease to be activated

  • 3 recalls, same reason

    • Terminated Z-0829-2015 FDA Class II initiated 7 Oct 2014
    • Terminated Z-0830-2015 FDA Class II initiated 7 Oct 2014
    • Terminated Z-0828-2015 FDA Class II initiated 7 Oct 2014

    MAKO has identified the potential that the shell impactors may be damaged intraoperatively.

    • Terminated Z-1508-2016 FDA Class II initiated 30 Apr 2014

    Revision of the field manual

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Mako
Generic Name
Radiological image marker, implantable
Device Name
TD-03 - MAKO - Class IIa - Screws - Consumables - Metal
Model / Ref / Catalog
116240, 08858251002253SH
Primary DI / UDI-DI
00848486002985
Basic UDI-DI
08858251002253SH
Direct Marketing DI
00848486002985
FDA Product Code
OLO
EMDN Code
Z12130485 Stereotactic orthopaedic surgery instruments - consumables
GMDN Term
Radiological image marker, implantable
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
882.4560
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II
ImplantableEUDAMED
No
GUDID
Yes

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Properties

  • Sterile
  • Single Use
  • Implantable NoEUDAMEDYesGUDID
  • CMR Substance
  • Prescription Use
  • Lot / Batch Number

Other properties (18)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No